DeviceClearance

Product code LYC— Dental

RESOLUT REGENERATIVE MATERIAL

Classification name
Bone Grafting Material, Synthetic
Device class
Class 2
Regulation
21 CFR 872.3930
Advisory panel
Dental
Total cleared
231
First cleared
Most recent

FDA classification definition

“A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.”

— U.S. Food and Drug Administration, device classification record for product code LYC under 21 CFR 872.3930, via openFDA

Market context for product code LYC

FDA has cleared 231 devices under product code LYC between 1979 and 2026, filed by 117 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code LYC

Recent clearances under product code LYC

1–100 of 231

Data sourced from openFDA. This site is unofficial and independent of the FDA.